Course topics include:

 

Overview of the days agenda

The criticality of calibration, A short history of calibration,

Requirements

21 CFR Part 820.72 (FDA – QSR), 21 CFR Part 820.25 (Training requirements),

21 CFR Part 58, 21 CFR Part 110, 21 CFR Part 211, and 21 CFR Part 606, ISO 9001:2008, ISO 13485:2003

A Quality Calibration Program

Calibration procedures – writing, formatting, and using them, Document control,

Updating and improving them, Training, Validation vs. qualification,

Calibration records, Specific requirements, The required items on a calibration form,

Formatting, Filing, electronic and hard copy, How to make corrections to your records,

Calibration labels, Calibration intervals, Calibration certificates, Traceability to the SI, TUR ≥ 4:1,

Uncertainty budgets, Equipment 'end of life' requirements, The correct way to state NIST traceability,

Complying with environmental requirements, Out of tolerance procedures, Myths about calibration & traceability

Examples of forms, Procedures and examples, Solutions for handling missing test equipment,

Managing a Quality Calibration Program,

Best practices and lessons learned,

Paperless Records using Adobe Acrobat Pro

If you have questions or need more information,
please send an email to: yokota-69@charter.net